The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Physicians use medical devices alone or in combination with drug therapies to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life.
Implantable medical devices are commonly used today to treat patients suffering from various ailments. Implantable medical devices can be used to treat any number of conditions such as pain, incontinence, movement disorders such as epilepsy and Parkinson's disease, and sleep apnea. Additional therapies appear promising to treat a variety of physiological, psychological, and emotional conditions. As the number of implantable medical device therapies has expanded, greater demands have been placed on the implantable medical device.
These devices may provide treatment therapy by delivering electrical stimulation or drugs to various portions of the body. In the case of providing electrical stimulation, an implantable neurostimulator (INS) (also known as an Implantable Pulse Generator ((IPG)) is implanted within the body. The INS is coupled to one or more electrodes that provide electrical energy to select portions of the body. In the case of providing drugs, a pump is implanted within the body The pump is coupled to a catheter that delivers drugs to select portions of the body.
When these implantable devices are implanted within the body, they must first be programmed to provide the desired treatment therapy. In present systems, the programming process usually involves two phases—a screening phase and an implant phase.
In the screening phase, the implanted system is tested to determine the amount of stimulation or drug that is necessary, to adjust the treatment parameters, and determine whether the therapy is efficacious. As shown in FIG. 1, a screener 110 is used by both the patient 115 and the physician. The screener 110 is generally hardwired to the implanted device such as a stimulation lead and has a plurality of controls 120 for adjusting the settings of the implanted device.
In the implant phase, the implanted device 210 is fully implanted within the body of the patient 115. As shown in FIG. 2, a physician programmer 230, typically a computer with associated electronics, is used to program and subsequently adjust the settings of the implanted device. The physician programer 230 is coupled to a telemetry unit 240 via a cable 235. The patient 115 may also adjust the settings of the implanted device 210 using a patient programmer 220 that communicates with the implanted device 210 via telemetry. During the implant phase, the physician or patient may seek to adjust settings of the treatment therapy for any number of reasons including, for example, to fine tune the therapy, to account for changes in the disease being treated, or to account for migration of the implanted lead or catheter.
Known systems for programming a medical device have a number of disadvantages. For example, both the physician and the patient must learn to use two separate devices, namely the screener and the physician/patient programmer. This requires additional learning time and requires that the physician or patient relearn how to use their respective programming devices. More importantly, settings that were made by the screener during the screening phase must be manually re-entered during the implant phase into the medical device using the physician programmer or the patient programmer. Not only does this unnecessarily waste valuable physician time, it can also result in human error in re-entering the settings.
The screener of the prior art also is also problematic. Since the screener uses different circuitry to provide the stimulation energy, the stimulus provided by the screener during the screening phase may not be identical to the stimulus provided by the implanted device. Thus, any settings made by the screener may require quite different settings by the implanted device. In a worst case, the screener settings may even go beyond the capabilities of the implanted device. This may then require the risk of a second surgical procedure to remove the implanted device and leads from the patient. Further, screeners typically have coarse knobs to control stimulus settings and, as a result, they don't always give precise stimulus settings. Even further, most screeners require sterile cables to go from the sterile field to the screener and the screener itself is not sterilize-able. The present invention overcomes these and other disadvantages of the prior art.